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Contract Manufacturing Organizations (CMOs) face constant challenges in the course of developing and manufacturing new pharmaceuticals or other products. And unfortunately, many drug development processes suffer from planning problems, as well as delays in development, unforeseen activities, cost overruns, and other losses. Many problems cannot be prevented, yet many of these shortcomings sometimes are the result of poor project planning in addressing the complexities of today’s projects.
While there are many unknowns in the development of New Chemical Entities (NCEs), Active Pharmaceutical Ingredient (API) manufacturing and custom chemistry projects, knowing where your project stands should not be one of them. Effective project management can help to make sure projects not only stay on track and on budget, but it also keeps all stakeholders informed every step of the way. This article will provide tips to help sponsors work together with their CMOs to keep projects on track.
One of the truism in any chemical product development project is that you don’t know how to get there unless you know where you are going. Because of this, it is critical that project managers understand the requirements, volumes, timelines and regulatory strategy for that particular compound. The project manager role comes with the need to have an acute understanding of the goals of the program. Everyone has his own unique and highly individual way of getting things done, but the mechanics of a successful project often are often shared by many successful project managers.
Below are the four key steps and considerations in ensuring effective project management:
Conduct a kick-off-meeting. To bring together different functional groups from the sponsor’s side, as well as the CMO’s, including analytical, regulatory and R&D experts, to define roles and responsibilities, set up a communication schedule and outline the various activities that need to take place. This meeting will set the tone for the entire program and reinforces the importance of communication throughout each step of the process. It should also include scientists assigned to the project and the sponsor’s business leaders.
Prior to this meeting, it’s important for the project manager to review the original proposal and make sure there is no disconnect. Likewise, make sure everyone is on the same page. Business departments and technical ones are not always in sync with their goals and drivers, so it’s important to talk this out. Also, between the time the proposal has been submitted and when it is approved we often see goals, objectives, technologies and quantities change, which all must be realigned in the proposal.
Here at Seqens, once a regular weekly meeting time is established, we provide a weekly agenda and minutes tracker to make sure everyone is up-to-date on what was discussed and resulting action items.
- Go backwards in time. It may sound counterintuitive, but develop a timeline that begins at the endpoint – what you hope to accomplish and when you need to deliver materials. From there it should incorporate the timeframe for conducting R&D, analytical development, tech transfer and chemical manufacturing. Project managers need to work with the team to determine how much material is needed, when it is needed and what the regulatory strategy entails. Once these are decided upon, then you can work backwards and decide what is realistic.
- Develop a Gantt chart. A detailed Gantt chart is a living document commonly used in project management. It can be one of the most useful ways of showing activities displayed against time. On the left of the chart is a list of the activities and along the top, each activity is represented by a bar. The position and length of the bar reflects the start date, duration and end date of the activity. This allows you to see at a glance what the various activities are, when each activity begins and ends, how long each activity is expected to last, the estimated start and end date of the whole project and budget tracking. This chart should be updated at least every other week and discussed in regular team meetings.
- Build-in set-backs. Even the best-made plans often go awry — people can under-estimate how much material they will need, yields may not be sufficient, scaling up may reveal purification problems, or delays in delivery of raw materials can set back projects. Effective project managers need to build these set-backs into their plans and readjust timelines accordingly, building these scope changes into the overall program chart amendments in real time. Most importantly, project managers need to keep an open line of communication with the sponsor to ensure complete transparency and notify the sponsor immediately of any problems that will impact the timeframe and costs of the project.
The role of project management in any API manufacturing program is never an easy one for CMOs, yet critical to the successful outcome. Using key tools and techniques, such as Gantt charts, timelines and reporting documents are helpful in making sure projects stay on track, yet none of these tools can replace the most effective ones: open and transparent communication between CMOs and their sponsors.
Our blog has lots of content about how to work more effectively with CMOs. Check out Process Research Best Practices, which describes ways to lower drug development costs and How to Keep CMO Costs Down During the Process Optimization Stage of Drug Development.